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Research Tree provides access to ongoing research coverage, media content and regulatory news on NEWRON PHARMACEUTICALS SPA. We currently have 3 research reports from 1 professional analysts.
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NEWRON PHARMACEUTICALS SPA
NEWRON PHARMACEUTICALS SPA
Xadago US approval slips out further
31 Mar 16
Newron has received a complete response letter from the FDA for its Parkinson’s disease drug Xadago (safinamide). Specifically, the FDA has requested clinical data on the potential effect of Xadago relating to abuse liability and dependence/withdrawal effects. No further efficacy or safety data for Xadago in patients with Parkinson’s disease has been requested. In next steps Newron will meet with Controlled Substance Staff (CSS) of the FDA to discuss exact requirements to address the issue. We anticipate that Newron will need to provide data relating to abuse liability and dependence in healthy subjects, and thus additional trials may be required. As such, we place our financial forecasts and valuation under review until we receive clarity on next steps and the potential impact on regulatory approval and market launch in the US
US partner on board ahead of PDUFA date
18 Mar 16
Commercial partner, Zambon, has announced a sublicence agreement with US WorldMeds for the US commercialisation of Parkinson’s disease (PD) therapy Xadago (safinamide). Under the agreement’s terms Zambon will give Newron a share of undisclosed, upfront milestone and royalty payments made by US WorldMeds, in addition to a milestone payment on FDA approval (we estimate €9m, not included in our forecasts). Importantly Xadago’s US PDUFA date is looming (29 March 2016) and a positive decision will clearly bode well for Newron’s share price. Our valuation of Newron remains unchanged at CHF504m or CHF35.5/share.
Xadago European roll-out continues
15 Mar 16
At its FY15 results Newron reported €0.5m (vs our €0.8m estimate) in royalties from commercial partner, Zambon after seven months of Xadago (Parkinson’s disease therapy) sales in Germany. So far in 2016 Zambon has also launched Xadago in Italy, Switzerland and Spain. The Xadago US PDUFA date is 29 March 2016, and a Xadago sublicensing deal in the US and a potential partnership for NW-3509 are on the cards. We have lowered our valuation slightly to CHF504m (vs CHF522m) primarily to reflect an increase in R&D expenses to support the mid-stage pipeline.
N+1 Singer - Morning Song 30-11-2016
30 Nov 16
Sanderson has delivered full year results in line with expectations and the 19 October trading update after a strong finish to the year compensated for a slower start. A healthy level of pre-contracted recurring revenue (50%), incremental sales to existing customers and new customer wins at higher average order values helped deliver solid revenue growth in both the Digital Retail (+9%) and Enterprise (+12%) divisions. A decent order book and good sales momentum suggest that the company is on track to deliver on unchanged profit expectations for the current year. We continue to view the valuation (FY17 EV/EBITDA 8.6x) as undemanding given an attractive combination of accelerating growth potential, strong cash generation and growing dividends.
30 Nov 16
Abzena (ABZA): Interim results indicate happy customers (BUY) | Horizonte Minerals* (HZM): Fund raise completed (CORP) | SacOil* (SAC): Half-year trading statement (CORP) | Revolution Bars (RBG): New openings (BUY) | Amino Technologies* (AMO): Multi operator FUSION roll out (CORP)
N+1 Singer - Morning Song 05-12-2016
05 Dec 16
RTHM is acquiring a profitable Canadian listed mobile specialist for equivalent of US$42.5m consideration in shares (88.235m). This helps adds to two growth vectors RTHM is targeting; (i) adds unique exclusive audience (10m unique) and (ii) Exclusive demand Yahoo and Facebook. The business has 15 premium and owned and operated apps which provide users with rewards for activity. The business is expected to deliver c$9m of EBITDA in FY18 including $2m of cost synergies. This equates to just 4.7x EV/EBITDA. This marks what we see the first step in RTHM activity to scale the business and deliver on margin potential (see our initiation notes). Our initial estimates for EPS revisions are very significant - for FY18 are 2.3 cents (currently 0.6) and for FY19 4.3 (currently 2.5). There is a call at 830 for investors and we will revise post this.
Panmure Morning Note 02-12-16
02 Dec 16
We expect CareTech to report FY results to September on 8th December. A positive trading update in October indicated that performance for the year was in line with market expectations therefore we are focusing on the outlook. We expect a confident statement since the end of 2016 showed positive trends across fee rates, expansion in places and occupancy. We believe CareTech is well positioned for further expansion, and remains at an attractive valuation. We retain our BUY and 380p price target.
Stuttering Generics weighs further on weak sentiment
30 Nov 16
Hikma gave a lacklustre Q3 16 trading update (no numbers) and has lowered its FY 16 revenue guidance (at cc) to $2bn from the previous $2-2.1bn. This was primarily on account of the continued sluggishness of the Generics segment. The Branded segment is also faring below expectations, besides facing higher-than-anticipated currency headwinds. The only positive is the sustained outperformance of the Injectables segment.